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Sen. Al Franken, D-Minn., on Friday held a conference with medical-device companies in Minnesota to discuss their views on the changes proposed by the FDA to the 510(k) process for clearing medical products. Franken is seeking a meeting with FDA Commissioner Margaret Hamburg in September to relay the industry's concerns about the changes in an effort to "continue to foster medical innovation and protect patient safety."

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Sen. Al Franken, D-Minn., sent a letter to Dr. Jeffrey Shuren, director of the FDA's device center, calling on the agency to seek comments from the U.S. medical device industry before making any changes to the 510(k) clearance process.

Sen. Al Franken, D-Minn., urged FDA Commissioner Margaret Hamburg to consider the concerns of the medical-device sector in Minnesota and elsewhere and gather further public comments as the agency works to introduce changes to the 510(k) process for clearing medical products. "We must continue to ensure patient safety, but not at the expense of innovation and the opportunities to get new products to the market that can improve patients' lives," Franken said after the Sept. 16 meeting.

Sen. Al Franken, D-Minn., on Friday held a conference with medical device companies in Minnesota to discuss their views on the changes proposed by the FDA to the 510(k) process for clearing medical products. Franken is seeking a meeting with FDA Commissioner Margaret Hamburg in September to relay the industry's concerns about the changes in an effort to "continue to foster medical innovation and protect patient safety."

Sen. Al Franken, D-Minn., on Friday held a conference with medical-device companies in Minnesota to discuss their views on the changes proposed by the FDA to the 510(k) process for clearing medical products. Franken is seeking a meeting with FDA Commissioner Margaret Hamburg in September to relay the industry's concerns about the changes in an effort to "continue to foster medical innovation and protect patient safety."